Perspective

Big Pharma on Campus: A Prescription

Laura Luczak

by ALISON BASS ’75

In June, a federal judge in South Carolina who fined Johnson & Johnson (J&J) $327 million for deceptively marketing its top-selling antipsychotic drug called the actions of the pharmaceutical giant “detestable.” He criticized J&J’s “concerted effort” to conceal information about the drug Risperdal’s side effects and cited the company’s “callous disregard for a patient’s right to have all information available” in deciding whether to take the drug.

This ruling is the latest in a long string of costly legal decisions against drug companies for hiding the truth about some of their products. In recent years, big names like J&J, Pfizer, Eli Lilly, Glaxo-SmithKline, Merck, Bristol-Myers Squibb and Forest Labs have been fined billions of dollars for hiding negative information about the side effects and effectiveness of their products and for illegally marketing drugs off-label — that is, prescribing drugs for an unapproved use. According to a recent Associated Press report, the pharmaceutical industry is the number one source of fraud-related settlements with the federal Department of Justice.

Yet what the news reports often fail to mention is that such corporate malfeasance is part of a larger problem within the burgeoning medical-industrial complex. Drug and medical device companies could not mislead the American public without the collusion of doctors, academic researchers, journals, professional societies and medical schools. All these constituencies benefit from the industry’s largesse and have little incentive to change the way drugs and medical devices are tested and sold.

I investigated the underbelly of this relationship in “Side Effects: A Prosecutor, a Whistleblower, and a Bestselling Anti-Depressant on Trial.” The book tells the story of Paxil, an antidepressant in the class of drugs known as selective serotonin reuptake inhibitors (SSRIs). Along with other brand-name SSRIs like Prozac, Zoloft and Celexa, Paxil was originally approved by the FDA for one specific purpose — the treatment of depression in adults.

Drug companies, however, heavily marketed these drugs for off-label uses as well, funding research into their use for treating children and adolescents suffering from social anxiety disorder and depression. Industry not only gave academic researchers millions of dollars to conduct such studies, but also paid many of the principal researchers millions on the side in personal consulting and speaking fees. Such financial conflicts of interest, which often went undisclosed, resulted in scientific misconduct — in this case, the suppression of negative research results to make these antidepressants look safer and more effective than they really are. In reality, Paxil not only proved ineffective in treating children and adolescents with depression, but it also made young users almost four times more likely to become suicidal than those taking a placebo. Just last year, the pharmaceutical giant paid $750 million to settle criminal and civil complaints that it sold a number of drugs with questionable safety and effectiveness, including Paxil.

The practice of selectively publishing only positive findings and hiding negative results has occurred with other blockbluster drugs, including Vioxx (a painkiller), Avandia (an anti-diabetes drug), Procrit (an anti-anemia drug), Vytorin (a cholesterol-lowering drug) and, of course, the antipsychotic Risperdal. Last year, Eli Lilly, AstraZeneca and Pfizer were fined hundreds of millions of dollars each for illegally marketing their antipsychotic drugs and concealing the fact that they caused serious side effects such as weight gain and diabetes.

Many proponents of industry-university partnerships, like the recently announced $100 million collaboration between Pfizer and Boston-area medical schools, maintain that such cooperation helps shore up the pharmaceutical industry’s sagging pipeline and bring beneficial drugs to market. They argue that academic researchers can help the industry with one of the biggest bottlenecks in drug development: testing compounds for efficacy in humans.

But too much industry funding threatens academic independence and integrity by steering academic researchers away from important work on vaccines and drugs for rarer diseases, such as Lou Gehrig’s, and toward commercially profitable “me too” drugs that have blockbuster potential but aren’t significantly better than what’s already on the market.

What’s at stake is the credibility of academic medicine. At a time when industry support is increasingly supplanting government funding, signs of the credibility crisis abound. For example, a national survey out this year showed that 53 percent of medical-school researchers in the United States have some kind of financial relationship with a drug company. Retractions of erroneous study results in medical journals have surged in the last decade. Some journals say this is because they are more vigilant in detecting errors, while others blame the competitive environment for research grants and the pressure that pharmaceutical companies exert on researchers to come up with positive findings in clinical trials.

A recent study in the Archives of Internal Medicine also found that, in one year alone, 25 out of 32 consultants (each earning at least $1 million in fees) to medical device companies failed to disclose their financial connections in journal articles published the following year, in violation of the journals’ disclosure policies.

Some reforms have been put in place. In 2007, Congress passed a law requiring drugmakers to disclose on a public website all clinical trial results, not just positive findings. While that’s a laudable first step, it is still too difficult for most consumers to make sense of the reams of raw data that have been posted.

Last year, as part of the health-care overhaul, Congress also passed the Physician Payment Sunshine Act, which requires drug companies starting in 2013 to make public a list of all doctors and researchers on their payroll. Several companies have already started posting that information in database form, but it remains difficult for consumers to fi nd individual doctors’ conflicts of interest.

Some prominent U.S. medical schools have taken steps to curb conflicts of interest among their faculty — for example, by limiting speaking fees and requiring full disclosure of consulting gigs and memberships on company scientific advisory boards. But they don’t go far enough. Academic institutions should prohibit researchers who are earning more than $10,000 in consulting and speaking fees from specific drug companies from doing research for those companies.

As the relationship between big pharma and academia promises to expand with the prospect of steep cuts to federal spending, additional reforms are needed. Clinical trials should be removed from the direct control of drug companies and administered by an independent federal agency with money pooled from industry and the federal government. In addition, academic institutions that receive industry funding should insist that products developed from the partnership be made available to the public “under reasonable terms,” as stipulated in the Bayh-Dole Act. This provision is almost universally ignored today, in large part because universities that license their research to industry have no control over the prices companies set. As a result, taxpayers pay twice: First they pay for much of the research, and then they pay for exorbitantly priced drugs.

The National Institutes of Health (NIH) should also begin enforcing their own conflict of interest rules by terminating grants to federally funded researchers who fail to disclose conflicts. Instead, university and industry lobbyists successfully pressured the NIH, which funds billions of dollars in basic life-science research, to drop a proposal that would have required universities to post on public websites the specific conflicts of interest of their federally funded researchers.

In the words of Justice Louis Brandeis, “Sunlight is the best disinfectant.” But in the prevailing climate, the stakeholders who should count the most — consumers — are too often left in the dark.